Engineer II - Quality Design Assurance

Engineer II - Quality Design Assurance Fridley

About Heraeus

Making displays foldable? Helping hearts beat with medical innovations? Or breathing new life into precious metals? As a family-owned global technology group we help our customers to always being one step ahead.

About Heraeus Medevio

Together we improve lives. At Heraeus Medevio, we bring lifesaving and life-changing medical devices to market through partnerships with medical device manufacturing companies. Backed by Heraeus Group, we are committed to the growth of our teams and organization by providing an open space for open minds.

To reach our vision of improving 100 million lives every year, we foster a culture of curiosity that thrives on challenge, continuous learning, growth, and the opportunity to try new things. With sites in the United States, European Union, and Asia, and over 2,200 employees worldwide, together, we will meet tomorrow's challenges today.

Position Summary

The Engineer II – Quality Design Assurance will be an engaged core project team member supporting the design and development of complex medical device products. The Engineer III – Quality Design Assurance represents the Quality Assurance function on multiple design and development projects, which can include catheters, guide wires, electrophysiology, and other related technologies. The Engineer III will work with a high degree of collaboration and attention to detail to assure adherence to product development and design controls processes.

What you'll get to do every day:

• Actively participate in complex medical device design and development projects, collaborating across functional areas to support and drive project deliverables to completion
• Support design and specifications for inspection and testing plans/procedures/systems to ensure products conform to specifications and quality standards.
• Propose and implement possible solutions/improvements, utilize the Corrective and Preventive Action (CAPA) system.
• Initiate, review, and approve disposition for nonconforming product.
• Review Change Orders, Deviation Authorizations, Verification/Validation Protocols, Final Qualification Protocol Reports, as well as Inspection Procedures.
• Lead efforts to continuously improve quality management systems and product quality, while ensuring safety, efficacy and regulatory compliance.
• Support all functional departments to ensure compliance with Quality System and lead continuous improvement efforts of the Quality System.
• Represent Quality Assurance on product development teams, including developing Quality Plans and Risk Management Plans.
• Provide input for quality management review.
• Facilitate customer audits and assist as needed with external audits such as FDA and ISO.
• May Investigate/analyze customer complaints and support Regulatory Affairs to monitor customer complaint trends and maintain compliance to complaint system.
• Maintain a positive demeanor while interacting with personnel from all areas of Medevio to foster improved quality and reduced cost.
• Promote a quality culture by clearly communicating the importance of adherence to procedure, providing rationale and context behind decisions, and seeking out areas for continuous improvement.
• May mentor and provide guidance to Quality Assurance Technicians.
• Ensure documentation accuracy and completeness of product and process development activities.
• Other duties assigned as required.

What we're looking for:

• Bachelor’s degree in Engineering or related field required.
• Minimum 2 years of experience in related engineering work.
• Experience in the medical device industry as a Quality Assurance Engineer strongly preferred.
• Experience with the use and application of gages, inspection tools, and test equipment.
• Practical experience/familiarity with some or all of the following: ISO 13485, FDA Quality System Regulations, Design Controls, Good Manufacturing Practices, Good Laboratory Practices, ISO 14971, MDR, sterilization processes, clean rooms, and other applicable standards.
• Must be able to read and understand component/product specifications.
• Ability to develop practical technical knowledge related to products that the position will support (guide wires,…